Study 2: Comparisons of Nicotine-Free Cigarettes, Extra Low Nicotine Cigarettes vs. Medicinal Nicotine
Smokers (N=150) will be enrolled in the study and will smoke ad libitum for a period of two
weeks during which time they will be assessed for baseline measurements. Subjects will then
be randomly assigned to one of the three conditions (N=50). Subjects will be blinded as to
whether they are assigned to the Quest nicotine-free vs. extra low nicotine condition. There
are no distinguishing features between these two cigarettes. Nicotine lozenge assignment is
open label. Subjects will be asked to use only their assigned study product (low nicotine,
nicotine-free cigarettes or lozenge) for a period of 6 weeks. Study cigarettes will be given
to them at each clinic visit and subjects will be told to smoke ad libitum. They will be
provided a supply equivalent to 150% of their baseline-smoking rate to allow for
compensatory smoking to occur. They will keep record of each cigarette they smoked. If
they smoked cigarettes other than those assigned to them, they will be asked to notate on a
sheet when that cigarette was smoked. At the end of the 6-week period, they will be asked to
quit smoking and NRT.
First morning urine and fasting blood samples will be collected at baseline and 2 and 6
weeks on the study products; at 6 weeks of abstinence and the 1 month follow-up.
Counseling. In each condition, subjects will be provided brief, structured counseling that
is similar in duration. The subjects in the cigarette conditions will discuss any
difficulties they experienced with switching cigarettes and problem solving these obstacles.
Problem solving each obstacle will be solicited from the subject. However, if no solution
or limited solution is provided, the counselor will provide a standardized response for each
of the obstacles confronted.
Follow-up Phase. Subjects will be followed up 1 month after the end of the 6 week
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Biomarkers for tobacco exposure measures: Carbon monoxide, cotinine, NNAL-gluc, NNN, mercapturic acids, 1-hydroxypytrene and biomarkers for cardiovascular risk: WBC, lipid profile, fibrinogen, heart rate, blood pressure.
Dorohty Hatsukami, Ph.D.
University of Minnesota - Clinical and Translational Science Institute
United States: Federal Government
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